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Medicinal cannabis: the route to good manufacturing practice registration

European Pharmaceutical Review

In this Q&A, EPR caught up with CEO James Short and Managing Director Arthur Wakeley from Celadon, to learn more about the company’s experience moving through, and progressing, the strict regulatory process for medicinal cannabis. James Short What were the key challenges for Celadon during the GMP registration process?

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Regulators Discuss Harmonization & Innovation, Regulatory Agility & Speed, & Workforce Skills

ISPE

Pound mentioned the MHRA Innovation Office , again stressing the need for early engagement. Pound said that MRAs were aligned with trade agreements, hence there could be challenges, and that ICMRA and PIC/S should be consulted by regulators as they should be helpful to the dialogue. Question: ICH Q13 was published Jan 2023.

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Regulators and Industry Discuss Digital Transformation and Pharma 4.0™

ISPE

Iacovelli stressed and Buendia concurred that digitization should be preceded by well-developed business cases that clearly define the purpose, target, and business value, then the “people aspects” of the change, and finally, the supporting technology. It must be people who make decisions about batch release.

FDA 97
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Why Balancing Blood Sugar is Vital for Hashimoto’s Health

The Thyroid Pharmacist

I often get asked if there is one thing that people with Hashimoto’s should do right away to feel better. Fortunately, the new USDA MyPlate no longer encourages people to eat the equivalent of one bread loaf’s worth of carbohydrates on a daily basis! One study followed 12 people with H. My answer is always, “There are two!